Agalsidase beta is used in the treatment of Fabry disease (a deficiency of alpha-galactosidase A enzyme) in adults and children at least 2 years old.

Agalsidase beta may also be used for purposes other than those listed here.

Tell your doctor if you have ever had:

• heart problems; or
• an allergic reaction to agalsidase beta or have antibodies to the medication.

Tell your doctor if you are pregnant or breastfeeding.

Your name may be listed on a Fabry disease patient registry. This is to track the progress of your disease and to evaluate the treatment effects of agalsidase beta. Taking part in this registry is especially important if you are pregnant or breast-feeding.

Use Agalsidase Beta (Fabrazyme) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction:

• wheezing, chest tightness, trouble breathing, feeling light-headed;
• skin rash, hives, flushing (warmth, redness, or tingly feeling);
• trouble swallowing; or
• swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you have any of these signs of an infusion reaction:

• chest pain, tightness in your throat, fast or slow heartbeats, pounding in your neck or ears;
• shortness of breath, stuffy nose, feeling hot or cold;
• tiredness, drowsiness, dizziness, feeling like you might pass out;
• rash, itching, numbness or tingling;
• nausea, vomiting, stomach pain, diarrhea; or
• headache, muscle pain, swelling in your hands or feet.

Common side effects may include:

• fever, chills, cough;
• dizziness;
• swelling in your hands or feet;
• numbness or tingling;
• feeling tired;
• rash; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.